Cleared Traditional

K964402 - VERSATRAC (TM) LUMBAR RETRACTOR SYSTEM

K964402 is an FDA 510(k) clearance for VERSATRAC (TM) LUMBAR RETRACTOR SYSTEM, manufactured by V. Mueller Neuro/Spine. The device is a Class 2 Neurology device with product code GZT cleared through the Traditional 510(k) pathway after a 80-day FDA review.

K964402 · V. Mueller Neuro/Spine · Neurology device
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Jan 1997
Decision
80d
Days
Class 2
Risk

K964402 is an FDA 510(k) clearance for the VERSATRAC (TM) LUMBAR RETRACTOR SYSTEM. Classified as Retractor, Self-retaining, For Neurosurgery (product code GZT), Class II - Special Controls.

Submitted by V. Mueller Neuro/Spine (San Carlos, US). The FDA issued a Cleared decision on January 23, 1997 after a review of 80 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.4800 - the FDA neurology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all V. Mueller Neuro/Spine devices

FDA 510(k) Submission Details - K964402

510(k) Number K964402 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 04, 1996
Decision Date January 23, 1997
Days to Decision 80 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
68d faster than avg
Panel avg: 148d · This submission: 80d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GZT Device Classification - Class 2, Special Controls

Product Code GZT Retractor, Self-retaining, For Neurosurgery
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.4800
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Neurology devices follow this clearance model.

Regulatory Peers - GZT Retractor, Self-retaining, For Neurosurgery

All 20
Devices cleared under the same product code (GZT) and FDA review panel - the closest regulatory comparables to K964402.
PIPELINE II ACCESS SYSTEM
K062814 · Depuy Spine, Inc. · Dec 2006
GROSSMAN SELF-RETAINING LOW PROFILE BRAIN RETRACTOR, MODEL 04-001-00
K060097 · KLS-Martin L.P. · Feb 2006
HARMONY PORT SYSTEM, MODEL 1907 SERIES
K050706 · Spinal Concepts, Inc. · Apr 2005
TEW CRANIAL/SPINAL RETRACTOR MODEL A1090
K960807 · Ohio Medical Instrument Co., Inc. · May 1996
CERVICAL SELF-RETAINING RETRACTOR
K935529 · T. Korossurgical Instruments Corp. · Mar 1994
CODMAN LHALO SPLIT RING RETRACTOR SYSTEM
K913233 · Codman & Shurtleff, Inc. · Jul 1991